Wow you're so kind! The active ingredient is Benzalkonium...

First 44 Last

Share
Profile

Follow
Tarvold

955 Posts.

86

11/09/18

13:52

Post #: 35521985
Share

Originally posted by JamieBar ↑

Hi Tarvold,

I did some more reading and research on your behalf,

AMOSIL is a trade named owned by Coating systems Laboratories. They are a competitor to Zoono and the owners of "Germ Free 24" as opposed to Zoono's "germfree24".
According to Zoono the active ingredient that provides 24 hr protection in Zoono is silane quaternary ammonium chloride, . Here is what the FDA has to say about using this product;

"To be included in the OTC Drug Review a product’s formulation and labeling must have existed in the marketplace in the United States on or before December 4, 1975, or be the subject of a final agency determination under 21 CFR 330.14. Pending a final monograph/rule, the Agency does not object to the marketing of products that meet both the formulation and labeling requirements described in the proposed rule. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of Section 505 of the FD&C Act (21 U.S.C. § 355).
We reiterate that silane quaternary ammonium chloride is not proposed as an active ingredient in the proposed rules/Tentative Final Monographs for topical antimicrobials. Nor does it appear to be otherwise included under the OTC Drug Review. Therefore, no topical antimicrobial product that includes silane quaternary ammonium chloride as an active ingredient is marketable under the OTC Drug Review even if the product includes an antimicrobial active ingredient that is covered under the OTC Drug Review.
We further note that according to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.
This communication does not constitute a written advisory opinion under 21 CFR 10.85, but rather is an informal communication under 21 CFR 10.85(k) which represents the best judgement of the employee providing it. This information does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the Agency to the views expressed.
It is the responsibility of firms that manufacture drug products to comply with all requirements of federal law and FDA regulations, and to ensure that its drug products are safe and effective and do not violate the provisions of the Federal Food, Drug, and Cosmetic Act".

Expand

Wow you're so kind!

The active ingredient is Benzalkonium Chloride not ammonium chloride.

Not sure what the point you're making with the FDA cut & paste.
Zoono products are classified as OTC drugs & therefore not subject to the same approvals that you've previously suggested are required. However the label has been reviewed & approved by the FDA & as such has all the approvals required to be sold in the US.
If the Zoono products are reclassified as non OTC drugs then yes they would be required to go through further approvals.

ZNO Price at posting: 8.0¢ Sentiment: Hold Disclosure: Held
2 Upvote

3 Great analysis

Reply

There are more pages in this discussion • 12 more messages in this thread...

First 44 Last

Add ZNO (ASX) to my watchlist

(20min delay)
Last 2.3¢		Change 0.000(0.00%)		Mkt cap ! $9.241M

Open	High	Low	Value	Volume
0.0¢	0.0¢	0.0¢	$0	0

Buyers (Bids)

No.	Vol.	Price($)
1	80500	2.4¢

Sellers (Offers)

Price($)	Vol.	No.
2.7¢	1937	1

View Market Depth

No.	Vol.	Price($)
1	4706	0.090
2	61000	0.085
1	25000	0.083
1	121951	0.082
1	10000	0.080

Price($)	Vol.	No.
0.092	4500	1
0.100	12000	1
0.110	10000	1
0.115	10000	1
0.120	1200	1

Last trade - 16.12pm 27/09/2024 (20 minute delay)

ZNO (ASX) Chart

Day chart unavailable

Wow you're so kind! The active ingredient is Benzalkonium...

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News